Local Coverage Article Response to Comments

Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) L38213

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Article ID
A57631
Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) L38213
Article Type
Response to Comments
Original Effective Date
12/16/2019
Retirement Date
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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, Wisconsin Physician Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF). The official notice period for the final LCD begins on October 31, 2019 and the final determination will become effective for services rendered on or after December 16, 2019.

Response To Comments

NumberCommentResponse
1

A device manufacturer, while “overall supportive of the draft,” recommended five revisions. The first recommendation was to cover symptomatic fractures “6+ weeks to 4-6 months old” in addition to acute fractures, “based on existing literature.

We appreciate the overall support of the draft, but cannot agree with extending coverage beyond acute fracture. The existing literature, if it supports vertebral augmentation at all (itself a particularly controversial proposition as documented in the draft), best supports it when the fracture is both acute (defined by time < 6 weeks), and symptomatic (mild to moderate pain) (1). The elimination of a required, fixed time of prior failed conservative management should facilitate referral during the acute phase. In addition, the draft coverage criteria acknowledges there may be an “acute on chronic” scenario where the original pain onset is greater than 6 weeks prior. Treatment of painful older osteoporotic vertebral fractures is the subject of, in-progress, VERTOS V (2).

2

A second recommendation noted: “there are patients who experience height loss and although it may not be >25%, they too experience significant pain,” and requested a specific percentage not be required.

We disagree. Most studies required some degree of height loss, and the >25% criterion is consistent with the multispecialty panel clinical care pathway (3).

3

The manufacturer also requested coverage of sacral osteoporotic fractures, without citing any supportive literature.

We disagree. Limiting coverage to thoraco-lumbar osteoporotic fractures is consistent with inclusion criteria in the major published studies (1,4-7).

4

A fourth manufacturer request was that a statement be added that “providers should follow the coverage criteria for cancer related fractures found in previous published LCDs.”

We disagree. The vast majority of Medicare payment is not addressed by a specific LCD or NCD, but only by the overarching statutory language that requires the service be “medically reasonable and necessary.” This guidance applies to compression fracture diagnoses outside the scope of the draft LCD.

5

Finally, the manufacturer noted “provider concern” with the draft wording that pedicle periosteal infiltration be considered as part of non-surgical management, citing two issues: 1/ it is not a billable procedure; and 2/ a pedicle fracture and treatment would be a contraindication per the LCD.

We disagree. This asterisked suggestion (not requirement) to “consider including pedicle periosteal infiltration” was included, not to treat pedicle fracture, but rather vertebral compression fracture; per VERTOS IV: “A future therapeutic pain strategy could be a combined regimen of periosteal infiltration during natural healing. Additional cementation seems indicated only in a selected subgroup of patients with insufficient pain relief after this early phase” (5).

6

An interventional radiologist, and industry consultant published on this topic, noted the “changes to the LCD are logical, beneficial for patients and reflect current literature based recommendations,” followed by five recommendations. The first noted: “allowing the treatment of severely painful acute fractures does not eliminate other fractures that would typically be treated along the traditional timeline,” and referred to “current criteria for treatment that extends out to four months.” The suggested modified criteria decouple the draft’s “acute” and “symptomatic” dual requirement into independent, standalone indications, implying that symptomatic fractures of any age should be eligible for vertebral augmentation (the other possible implication is treatment of acute fractures, even if minimally symptomatic).

We appreciate the kind words, but cannot agree with making acute and symptomatic independent indications. See response to comment #1.

7

The next comment by this clinician noted that the “fracture of the posterior column” exclusion was redundant; it is subsumed under the “unstable spinal fracture” exclusion.

We agree and deleted.

8

A third comment objected to the multidisciplinary team consensus requirement (simultaneous with documentation of an acute, symptomatic fracture). The commenter maintains “that the treatment recommendation alone is adequate for treatment as long as it comes from a multidisciplinary team but is not required for treatment as a multidisciplinary team is most often not available.”

We disagree. The consensus is necessary but not sufficient. The additional multidisciplinary team consensus requirement is suggested by 2017 Cardiovascular and interventional Radiological Society of Europe (CIRSE) guidelines (8), and reinforced by the long-standing (and recently heightened) controversial nature of vertebral augmentation.

9

The fourth recommendation was for wholesale adoption of the exclusion criteria, and format, “developed by the multidisciplinary expert group using the RAND/UCLA appropriateness criteria methodology…..the same set of recommendations used to update the inclusion criteria” (3).

We agree to adopt a hybrid, more nuanced, gradated approach (i.e., stratification into absolute and relative contraindications) similar to that recommended. We also agree to include relative contraindications cited by the expert group missing from the draft.

10

The final recommendation (matching the sole comment received from another clinician) cited the “other cause of back pain” exclusion as being too general since “the vast majority of patients are elderly and have some longstanding back pain.” It was pointed out that the “spirit of this exclusion is meant to make sure that the clinician confirms the fracture seen on imaging is the main cause of the patient’s back pain.”

We agree. The phrasing is not specific enough; the revised exclusion wording is “Current back pain is not primarily due to the identified acute VCF(s).”

11

The American Society of Anesthesiologists (ASA) commented: “The Society is pleased with the analysis of evidence regarding the rationale for the coverage determination but seeks clarification….in regard to multidisciplinary team consensus and the treating physician performing PVA.” They note that the current requirement for: “Multidisciplinary team consensus (referring physician (e.g., rheumatologist, endocrinologist), treating physician (i.e., performing the PVA), radiologist, neurologist)” limits the treating physician to either a radiologist or neurologist. They recommend changing the wording to “Multidisciplinary team consensus (referring physician (e.g., rheumatologist, endocrinologist), treating physician (e.g.., performing the PVA), radiology, neurology, anesthesiology, interventional pain management).”

This comment reflects a misinterpretation. Recognizing that a variety of specialties perform vertebral augmentation, we simply referred to them collectively as “treating physician,” further defined by the parenthetical “i.e., performing the PVA.” The following reference to radiologist and neurologist are additional members of the multidisciplinary team (in addition to the referring and treating physicians). The format has been modified to make this clearer.

12

The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) submitted a joint comment proposing several revisions. The first recommendation is “that the 6-week limitation be removed.” They note: “while some of the clinical trials elected to choose six weeks as an arbitrary cut-off point for enrollment, there is no evidence that benefit is lost beyond six weeks,” citing the FREE study (7) as an example of “high-quality” evidence of benefit “with fracture age up to 3 months.”

We disagree. The FREE study was among the first generation of RCTs which were open-label (unblinded) and vulnerable to placebo effect. The subsequent generation of RCTs, having addressed this flaw, struggle to show a benefit of vertebral augmentation. Please see response to comment #1.

13

A second AANS/CNS recommendation was to drop the statement, “consider including pedicle periosteal infiltration” as it “is not considered the standard of care, and despite it being used as a sham active control in the VERTOS IV study.”

See response to comment #5.

14

A third AANS/CNS recommendation was to drop the multidisciplinary team consensus requirement, noting “the treating physician, whether a neurosurgeon, interventional radiologist, or other specialist, should have the freedom to make independent decisions based on the clinical scenario.”

See response to comment #8.

15

A final set of AANS/CNS recommendations focused on the exclusion criteria, suggesting a less restrictive approach similar to that recommended in comments #9 and #10. The one unique recommendation was to eliminate the “greater than three vertebral fractures” contraindication, noting: “Determining the actual age of a fracture is extremely difficult, and excluding patients based on the number of fractured vertebrae may limit the benefit of intervention to many patients.”

Please see responses to comments #9 and #10. Regarding the three fracture limit, this is consistent with most of the studied population (1,5-7,9).

16
  1. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016;388(10052):1408-1416.
  2. A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V) (VERTOSV). https://clinicaltrials.gov/ct2/show/NCT01963039.
  3. Hirsch JA, Beall DP, Chambers MR, et al. Management of vertebral fragility fractures: A clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018.
  4. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579.
  5. Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018;361:k1551.
  6. Beall DP, Chambers MR, Thomas S, et al. Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial. Neurosurgery. 2018.
  7. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024.
  8. Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017;40(3):331-342.
  9. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.

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